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CTRI Number  CTRI/2023/10/059193 [Registered on: 27/10/2023] Trial Registered Prospectively
Last Modified On: 26/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Interrelationship between Quadriceps Angle, Iliotibial Band Flexibility, and Hamstring to Quadriceps ratio in young recreational runners with Anterior Knee Pain. A Crossectional Analytical Study 
Scientific Title of Study   Correlation between Quadriceps Angle, Iliotibial Band Flexibility, and Hamstring to Quadriceps ratio in young recreational runners with Anterior Knee Pain. A Crossectional Analytical Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prachi Misal 
Designation  Masters o Physiotherapy Student 
Affiliation  KJ Somaiya College Of Physiotherapy, Sion 
Address  OPD 4 and 5, K J Somaiya college of physiotherapy, Ayurvihar, Eastern express highway, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  8169232164  
Fax    
Email  prachi.misal@somaiya.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Priti Mehendale 
Designation  Associate professor 
Affiliation  K J Somaiya college of Physiotherapy, Sipn 
Address  OPD 4 and 5, K J Somaiya college Of Physiotherapy, Ayurvihar, Eastern express Highway, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9821533846  
Fax    
Email  priti.mehendale@somaiya.edu  
 
Details of Contact Person
Public Query  
Name  Prachi Misal 
Designation  Masters Of Physiotherapy Student 
Affiliation  KJ Somaiya college of Physiotherapy, Sion 
Address  OPD 4 and 5, K J Somaiya College Of Physiotherapy, Ayurvihar, Eastern Express Highway, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  8169232164  
Fax    
Email  prachi.misal@somaiya.edu  
 
Source of Monetary or Material Support  
OPD 4 and 5, K J Somaiya college of physiotherapy, eastern express highway, Ayurvihar, Sion, Mumbai 
 
Primary Sponsor  
Name  KJ Somaiya College Of Physiotherapy  
Address  Eastern express highway, Ayuvihar, Sion 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prachi Misal  KJ Somaiya College Of Physiotherapy  OPD 4 and 5, K J Somaiya College Of Physiotherapy, Ayurvihar, Eastern Express Highway, Sion, Mumbai
Mumbai
MAHARASHTRA 		 8169232164

prachi.misal@somaiya.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee KJ Somaiya College of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Individuals in the age group 20-40 years with Anterior knee pain (VAS score 4 to
7), all genders, lasted not more than 6 months. 
 
ExclusionCriteria 
Details  1.Individuals with history of trauma, infections, inflammation, metabolic disorders
to Lumbar Spine, Hip, Knee, Ankle, foot,
2.Individuals with congenital anomalies of lumbar spine, hip, knee, ankle, foot.
3.Individuals with pathology of lumbar spine, hip, knee, ankle, foot. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Q angle
It band tightness- adduction angle
Isokinetic dynamometer 		 One time assessment 
 
Secondary Outcome  
Outcome  TimePoints 
To assess functional status of young runners with anterior knee pain using Anterior Knee Pain Scale/Kujala Score.  One time assessment 
 
Target Sample Size   Total Sample Size="61"
Sample Size from India="61" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/11/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Approval is obtained from Institutional Ethics Committee. Participants fitting the inclusion criteria will be recruited and a written informed consent will be obtained in the language best understood by them. Demographic data(Age,gender,height,weight) will be obtained and filled in the case record sheet. If case of bilateral affection, the knee with higher VAS score will be considered. In affected leg, the maximum peak torque for the Hamstring and quadriceps muscles will be detected , H:Q ratio will be measured and isokinetic data will be printed. In standing,Q angle will be measured.Adduction angle will be measured using ober’s test. Statistical analysis will be done using pearson’s corelation coffecient test (if data passes through normality) or spearman corelation coefficient test ( if data does not pass through normality). 
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